Evaluation of Web-Based Recovery Monitoring With Clinical Alerts

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01465555
First received: November 1, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The specific aims of the project are to conduct a three-phase study to develop a data-driven Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and test its efficacy, as follows:

Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that predicts early treatment attrition; adapt elements of a cognitive behavioral intervention (CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three monitoring assessments to inform counselors when a client is at High Risk to leave treatment.

Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the study measures/procedures.

Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors were assigned to TAU (control condition). The primary hypothesis is that clients who evidence a High Risk for attrition will have longer lengths of stay in the Clinical Alerts + CBI condition than High Risk clients in the control condition. Secondary client hypotheses are that High Risk clients in the Clinical Alert + CBI condition will attend more treatment sessions, have more drug-free urine results, and receive more ancillary services than High Risk clients in the control condition.


Condition Intervention Phase
Substance Abuse
Behavioral: Cognitive Behavioral Intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Web-Based Recovery Monitoring With Clinical Alerts

Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Length of stay [ Time Frame: 3 months post consent ] [ Designated as safety issue: No ]
    Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.


Secondary Outcome Measures:
  • Number of treatment sessions [ Time Frame: 3 months after consent ] [ Designated as safety issue: No ]
    The number of treatment sessions the client attended will be obtained from the treatment program clinical record.

  • Urine drug screen results [ Time Frame: 3 months post consent ] [ Designated as safety issue: No ]
    The urine drug screen results for each client will be obtained from the treatment program clinical record.

  • Number of treatment services [ Time Frame: 3 months post consent ] [ Designated as safety issue: No ]
    Number of treatment services will be obtained from the client as self report at the 1, 2, and 3 Month follow-up.


Enrollment: 389
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinical Alert
Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.
Behavioral: Cognitive Behavioral Intervention
Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.
No Intervention: Treatment As Usual
Counselors in this condition will work with the original RecoveryTrack which has not been altered to provide automated Clinical Alerts for High Risk patients. Supervisors will receive no automated help in identifying these clients in the counselors' caseloads. The Clinical Alert feature will not be discussed in the training these counselors receive. Rather, the counselors will receive an attention-control training, a one-day training on assessment and treatment planning, with monthly tips and reminders for six months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
  • Counselor employed at participating facility.

Exclusion Criteria:

  • Client unable to speak English
  • Client too cognitively impaired to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465555

Locations
United States, Delaware
Kent Sussex Counseling Services
Dover, Delaware, United States, 19904
Brandywine Counseling & Community Services
Wilmington, Delaware, United States, 19805
United States, New Jersey
Genesis Counseling Centers
Collingswood, New Jersey, United States, 08108
United States, Pennsylvania
Sobriety Through Outpatient
Philadelphia, Pennsylvania, United States, 19132
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: Adam C Brooks, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01465555     History of Changes
Other Study ID Numbers: R01DA026469, R01DA026469
Study First Received: November 1, 2011
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
Clinical Alert
Cognitive Behavioral Intervention
Web-based
Substance Abuse Treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014